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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64250
Product Type Devices
Status Ongoing
Recalling Firm Baylis Medical Company Inc.
City Mississauga
State ON
Country CA
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-04
Initial Firm Notification of
Consignee or Public
Distribution Pattern International distribution to the country of Australia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain. Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811. Class II A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages were identified prior to use. 1780 Z-0879-2013